Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease

Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Overall survival defined as patient being alive at 1 year post-transplant. Monitoring will take place separately for the single and double UCBT cohorts.

Analysis population is all patients who underwent UCB transplant on study, whether completed treatment on study or relapsed at later timepoint.

→

secondary · POSTED

Peripheral blood chimerism studies (sorted for CD3, CD14, CD33, CD56 cells) were collected for all UCBT recipients for days 28, 56, 80, 365, and 730 post-transplant. The combined median of the percent donor, along with full range, is captured to show change in level of chimerism at multiple time points up to 2 years post-transplant. Monitoring will take place separately for the single and double UCBT cohorts.

Participants who received UCBT on study with chimerism data available within window as specified in protocol.

→

secondary · POSTED

Defined as death due to complication (other than relapse) within 6 months following UCBT. Monitoring will take place separately for the single and double UCBT cohorts.

Analysis population is all patients who underwent UCB transplant on study.

→

secondary · POSTED

Neutrophil engraftment after UCBT is defined as the first day of absolute neutrophil count (ANC) ≥ 5 x 10⁸/L for 3 consecutive measures. Monitoring will take place separately for the single and double UCBT cohorts.

Analysis population is all patients who underwent UCB transplant and experienced ANC engraftment by day 42 post-transplant on study. 4 patients did engraft ANC after day 42 post-transplant, but are not included in this analysis due to protocol definition of engraftment period.

→

secondary · POSTED

Platelet (PLT) engraftment after UCBT is defined as the first day of platelet count \> 20,000/μl without subsequent transfusions for 7 days. Monitoring will take place separately for the single and double UCBT cohorts.

Analysis population is all patients who underwent UCB transplant and experienced PLT engraftment by 6 months post-transplant on study.

→

secondary · POSTED

Each event of aGVHD will be assigned an overall aGVHD score based on extent of skin rash, volume of diarrhea, and maximum bilirubin level, per protocol Appendix I, "GVHD Staging and Grading." Scores reported range from most mild at 2, to worse at 4. Monitoring will take place separately for the single and double UCBT cohorts.

Participants who received UCBT on study.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
nct id: NCT00719888
trial label: Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease
applicability: unclear
applicability note: Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
nct id
NCT00719888
outcome key
om-0000
source section id
NCT00719888-om-0000
source outcome index
0
endpoint
Overall Survival
endpoint definition
Overall survival defined as patient being alive at 1 year post-transplant. Monitoring will take place separately for the single and double UCBT cohorts.
time origin
1 year post-transplant
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Analysis population is all patients who underwent UCB transplant on study, whether completed treatment on study or relapsed at later timepoint.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
nct id
NCT00719888
outcome key
om-0001
source section id
NCT00719888-om-0001
source outcome index
1
endpoint
Change in Level of Chimerism at Multiple Time Points
endpoint definition
Peripheral blood chimerism studies (sorted for CD3, CD14, CD33, CD56 cells) were collected for all UCBT recipients for days 28, 56, 80, 365, and 730 post-transplant. The combined median of the percent donor, along with full range, is captured to show change in level of chimerism at multiple time points up to 2 years post-transplant. Monitoring will take place separately for the single and double UCBT cohorts.
time origin
Baseline up to 2 years post-transplant
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants who received UCBT on study with chimerism data available within window as specified in protocol.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
nct id
NCT00719888
outcome key
om-0002
source section id
NCT00719888-om-0002
source outcome index
2
endpoint
Incidence of Transplant-related Mortality (TRM)
endpoint definition
Defined as death due to complication (other than relapse) within 6 months following UCBT. Monitoring will take place separately for the single and double UCBT cohorts.
time origin
At 6 months post-transplant
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Analysis population is all patients who underwent UCB transplant on study.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
nct id
NCT00719888
outcome key
om-0003
source section id
NCT00719888-om-0003
source outcome index
3
endpoint
Neutrophil Engraftment
endpoint definition
Neutrophil engraftment after UCBT is defined as the first day of absolute neutrophil count (ANC) ≥ 5 x 10⁸/L for 3 consecutive measures. Monitoring will take place separately for the single and double UCBT cohorts.
time origin
Up to day 42 post-transplant
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Analysis population is all patients who underwent UCB transplant and experienced ANC engraftment by day 42 post-transplant on study. 4 patients did engraft ANC after day 42 post-transplant, but are not included in this analysis due to protocol definition of engraftment period.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
nct id
NCT00719888
outcome key
om-0004
source section id
NCT00719888-om-0004
source outcome index
4
endpoint
Platelet Engraftment
endpoint definition
Platelet (PLT) engraftment after UCBT is defined as the first day of platelet count \> 20,000/μl without subsequent transfusions for 7 days. Monitoring will take place separately for the single and double UCBT cohorts.
time origin
Up to 6 months post-transplant
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Analysis population is all patients who underwent UCB transplant and experienced PLT engraftment by 6 months post-transplant on study.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
nct id
NCT00719888
outcome key
om-0005
source section id
NCT00719888-om-0005
source outcome index
5
endpoint
Event of Grade II-IV and III-IV Acute Graft-versus-host Disease (aGVHD)
endpoint definition
Each event of aGVHD will be assigned an overall aGVHD score based on extent of skin rash, volume of diarrhea, and maximum bilirubin level, per protocol Appendix I, "GVHD Staging and Grading." Scores reported range from most mild at 2, to worse at 4. Monitoring will take place separately for the single and double UCBT cohorts.
time origin
Up to day 100 post-transplant
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants who received UCBT on study.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
nct id
NCT00719888
outcome key
om-0000
arm key
OG000
arm label
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant
regimen
Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
analyzed count
33
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00719888-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
nct id
NCT00719888
outcome key
om-0000
arm key
OG001
arm label
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant
regimen
Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00719888-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
nct id
NCT00719888
outcome key
om-0000
arm key
OG002
arm label
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant
regimen
Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
analyzed count
72
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00719888-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
nct id
NCT00719888
outcome key
om-0000
arm key
OG003
arm label
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant
regimen
Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00719888-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
nct id
NCT00719888
outcome key
om-0001
arm key
OG000
arm label
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant
regimen
Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
analyzed count
33
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00719888-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
nct id
NCT00719888
outcome key
om-0001
arm key
OG001
arm label
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant
regimen
Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00719888-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
nct id
NCT00719888
outcome key
om-0001
arm key
OG002
arm label
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant
regimen
Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
analyzed count
72
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00719888-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
nct id
NCT00719888
outcome key
om-0001
arm key
OG003
arm label
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant
regimen
Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00719888-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
nct id
NCT00719888
outcome key
om-0002
arm key
OG000
arm label
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant
regimen
Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
analyzed count
33
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00719888-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
nct id
NCT00719888
outcome key
om-0002
arm key
OG001
arm label
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant
regimen
Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00719888-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
nct id
NCT00719888
outcome key
om-0002
arm key
OG002
arm label
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant
regimen
Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
analyzed count
72
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00719888-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
nct id
NCT00719888
outcome key
om-0002
arm key
OG003
arm label
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant
regimen
Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00719888-om-0002#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
nct id
NCT00719888
harm key
EG000
source section id
NCT00719888-ae
event group key
EG000
event group label
Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide
serious affected
47
serious at risk
108
other affected
73
other at risk
108
frequency threshold
0
collection period
Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death.
event definition
For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-breyanzi-d7856c17
nct id
NCT00719888
harm key
EG001
source section id
NCT00719888-ae
event group key
EG001
event group label
Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa
serious affected
7
serious at risk
27
other affected
25
other at risk
27
frequency threshold
0
collection period
Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death.
event definition
For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice